Parte Seconda n. 90 del 31-7-2010
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
DR. WILLMAR SCHWABE GMBH &amp; CO. KG
(GU Parte Seconda n.90 del 31-7-2010)

Modifica secondaria di un'autorizzazione all'immissione in commercio
di una specialità medicinale per uso umano. Modifica apportata ai
sensi del Decreto Legislativo 29 dicembre 2007,n. 274

Titolare AIC: Dr. Willmar Schwabe GmbH &amp; Co. KG, con sede in
Willmar-Schwabe-Str. 476227 Karlsruhe Germany,
Specialità Medicinale: DORMIPLANT 160mg + 80mg compresse rivestite
con film
Confezioni e numero AIC:
10 compresse - AIC n. 033892011;
14 compresse - AIC n. 033892023;
15 compresse - AIC n. 033892035;
20 compresse - AIC n. 033892047;
30 compresse - AIC n. 033892050;
40 compresse - AIC n. 033892062;
45 compresse - AIC n. 033892074;
50 compresse - AIC n. 033892086;
60 compresse - AIC n. 033892098;
90 compresse - AIC n. 033892100;
100 compresse - AIC n. 033892112;
25 compresse - AIC n. 033892124
Codice Pratica N1A/2010/4889
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.III.2) Change to comply with Ph. Eur., c) Change
in specifications from a national pharmacopoeia of a Member State to
the Ph.Eur.: specifications for Valeriana, herbal preparation are
changed from DAB 10 to Ph. Eur. monograph "Valeriana root"
Codice Pratica N1A/2010/4891
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.b.1) Change in the specification parameters
and/or limits of an active substance, starting material
/intermediate/reagent used in the manufacturing process of the active
substance, b) Tightening of specification limits: The specification
for determination of content of rosmarinic acid has been tightened in
order to comply with Ph. Eur.
Codice Pratica N1B/2010/3272
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IB B.I.a.2) Changes in the manufacturing process of
the active substance, a) Minor change: inclusion of one further step
in the manufacturing process (Short term heating)
Codice Pratica N1A/2010/4895
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.e.1) Change in immediate packaging of the
finished product, a) Qualitative and quantitative composition, 1)
Solid pharmaceutical forms: from PVC foil to PVC/PVDC foil
Codice Pratica N1A/2010/4896
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.a.4) Change to in-process tests or limits
applied during the manufacture of the active substance, b) Addition
of a new in-process test and limits: IPC test (Extraction agent) and
parameter (Ethanol content) are added.
Codice Pratica N1B/2010/3273
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IB B.II.d.2) Change in test procedure for the
finished product, d) Other changes to a test procedure (including
replacement or addition): The HPLC fingerprint has been replaced by
the TLC fingerprint
Codice Pratica N1A/2010/4902
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.d.2) Change in test procedure for the
finished product, a) Minor changes to an approved test procedure:
HPLC test method for Valerian root extract.
Codice Pratica N1A/2010/4906
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.III.2) Change to comply with Ph. Eur. c) Change
in specifications to the Ph. Eur: Herbal preparation - Valeriana -
specifications were adapted to Ph. Eur. monograph
Codice Pratica N1A/2010/4907
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.III.2) Change to comply with Ph. Eur. c) Change
in specifications from a national pharmacopoeia of a Member State to
the Ph. Eur: specifications for Valeriana, herbal substance were
changed from DAB 10 to Ph. Eur. Monograph "Valerian root".
Codice Pratica N1A/2010/4893
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IAIN B.III.2) Change to comply with Ph. Eur. a)
Change of specification(s) to comply with the Ph. Eur., 1) Active
substance: Specifications for Melissa herbal preparation were adapted
to Ph. Eur. Monograph Melissae folii extractum siccum* (*Melissa leaf
dry extract)
Codice Pratica N1A/2010/4892
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.III.2) Change to comply with Ph. Eur., c) Change
in specifications to the Ph. Eur: The specifications for Melissa
herbal substance were adapted to the Ph. Eur. Monograph "Melissa
leaf"
Codice Pratica N1B/2010/3271
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IB B.II.f.1.d) Change in the storage conditions of
the finished product: Addition of a remark that the finished product
should not be stored above 30° C.
Codice Pratica N1A/2010/4900
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.d.1a) Change in the re-test period/storage
period of the active substance where no Ph. Eur. Certificate of
Suitability covering the retest period is part of the approved
dossier, 1) Reduction: (Melissa) from 12 months to 6 months
I lotti già prodotti alla data della pubblicazione in Gazzetta
Ufficiale possono essere mantenuti in commercio fino alla data di
scadenza indicata in etichetta.

Head Of International Regulatory &amp; Scientific Affairs
Dr. U. Mathes


T10ADD8632